Flixabi is now approved to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Flixabi demonstrated comparable safety and equivalent efficacy to Remicade in a 54-week phase III clinical study.
The ACR20 response rate was 65.3% in the Flixabi unit, compared to 69.2% in the Remicade arm at week 54, supporting the 30-week study results of 64.1% and 66%, respectively.
About 584 patients were randomized in the study with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.
Samsung Bioepis’ European sales and marketing partner Biogen will commercialize Flixabi in the European Union member states as well as in Norway, Iceland and Liechtenstein.
Samsung Bioepis president & CEO Christopher Hansung Ko said: "With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe."
Flixabi is Samsung Bioepis’ second biosimilar to secure the EC approval. Benepali, the company’s biosimilar drug referencing Enbrel (etanercept), was approved earlier this year.
Earlier this month, the US Food and Drug Administration (FDA) accepted for review Samsung Bioepis’ biologics license application (BLA) for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
Samsung is seeking approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired.
Image: An engineer at the Samsung Bioepis R&D Center. Photo: courtesy of Business Wire.